The present invention relates to a herbal formulation useful for treatment of skin disorders like dry eczema and corns on the feet and for alleviating muscular pain due to exertion. The herbs that are used in this invention are known to possess activity against eczema and corn and they also possess analgesic property.
Eczema is a generic term for acute or chronic inflammatory condition of the skin, typically erythematous, edematous, papular, vascular and crusting followed by lichenification and scaling and occasionally by duskiness of erythema infrequently by hyper pigmentation, often accompanied by sensation of itching and burning. It is also called as dry tetter.
Dermatitis is eczematous unless specifically stated to the contrary. The earliest sign of eczema is erythema, occasioned by dilatation of dermal blood vessels, and this persists to a greater or lesser degree until healing takes place. The next stage consists of invasion of epidermis by lymphocytes and an increase in its cellular and intercellular fluid. The latter collects in to minute vesicles. The vesicles soon rupture, leading to exudation of serum onto the surface, which after some time dry up and form crusts. As a result of these changes, the normal function of epidermis is interfered with. It: fails to form healthy horn cells, the surface of the skin becoming scaly (parakeratosis). Also, the cellular division may be increased leading to general thickening of the epidermis which when extreme, results in xe2x80x9clichenificationxe2x80x9d.
Corns referred to as hyperkeratosis, result from friction and pressure, and the skin responds by becoming thicker and tougher as a protective mechanism. The horny, outer layer of the skin called the xe2x80x9cstratum corneumxe2x80x9d becomes thicker in the area where there is an increased pressure or rubbing. A corn has a hard core, a bit like an upside down pyramid, with the base at the surface of the skin, and the point pushing inward. When this point presses against the nerve endings in the nearby tissue, a stabbing pain may the result. The treatment of corns begins by attacking the cause, preventing the friction and relieving the pressure on the area. Specially medicated plasters containing chemicals that can dissolve the tissue (keratolytics.).
Treatment of eczema consists use: of corticosteroids such as hydrocortisone and other steroidal anti-inflammatory drugs. Drugs like Betamethasone valerate and Clobetasone propionate were used topically as creams containing betamethasone valerate 0.12% and clobetasone 0.05%.
For treating corns, presently, xe2x80x9ccorn capsxe2x80x9d are available in the market (manufactured) by Indoteck Laboratories, Rohtak, India) a corn dressing which contains salicylic acidxe2x80x9430%, Benzoic acidxe2x80x9410% and Saraca indicaxe2x80x9410% w/w. The ingredients have keratolytic property. The disadvantages with the presently available commercial product are that different sizes of caps are necessary depending on the size of the corn on the toes. The corn caps should not be used in cuts and burns. Also, the preparation is contraindicated in diabetic patients.
Accordingly, studies were undertaken to develop cream formulations containing herbal drugs and synthetic ingredients for topical application over the affected areas which will help in alleviating muscular pain due to exertion and for reducing itching and burning sensation in cases of eczema and reducing the pain in places where corns are present.
The main object of the present invention is to provide a novel herbal formulation useful for treatment of skin disorders and alleviating muscular pain.
Another object is to provide a formulation useful for the treatment of eczema and corn.
Yet another object of the present invention is to provide a method for the treatment of skin disorders and muscular pain using the formulation of the invention.
Accordingly, the invention provides a novel herbal formulation useful for the treatment of skin disorders and comprising two or more plant extracts selected from Tagetes erecta, Moringa oleifera, Ocimum sanctum, Tridax procumbens, Aloe vera, and Gum olibanum together with conventional additives.
Accordingly, the present invention provides a novel herbal formulation useful for alleviating muscular pains and for treating skin disorders such as eczema and corns, said formulation comprising:
a) two or more plant extracts in the form of oil or extracts or powder or mixtures thereof, the plants extracts being selected from the group comprising Tagetes erecta 1 to 5 wt. %, Moringa oleifera 2 to 4 wt. %, Ocimum sanctum 0.3 to 3 wt. %, Tridax procumbens 2 to 6.5 wt. %, dried juice of Aloe vera 2 to 6.5 wt. %, Gum olibanum powder in natural state 3 to 6 wt. %, and Gum olibanuim resinoid or organic extract 3 to 6 wt. %; and one or more of the following:
b) drugs having anti-inflammatory and wound healing property and present in the range of 0.02 to 5 wt %;
c) a base containing aqueous cream or gel in the range of 2 to 5 wt. %;
d) emulsifying ointment in the range of 26 to 42 wt. %;
e) one or more preservatives in the range of 0.1 to 0.2 wt. %;
f) a humectant 0.5 to 3%; and
g) the balance being water or propylene glycol and water in the ratio of 50:50 to make 100 wt. %.
The novelty of the present investigation is (1) does not require high dosage of drugs like beta methasone valerate, clobetasone propionate and salicylic acid in the cases of eczematic conditions. (2) since the formulation is to be applied on the affected areas of the skin it obviates the need for different sizes of the corn caps which are available commercially. (3) unlike commercial formulations which act by counter irritant action for the relief of muscular pains, the present formulation acts increasing blood flow by dilating the blood vessels when applied on the affected skin areas.
In an embodiment, the plant extracts used may be Tagetes Erecta, Moringa Oleifera, Ocimium Sanctum, Gum Olibanum, Tridax Procumbens, Sandal wood, Aloe Vera from any part of the plant such as leaf, root, bark, natural exudation of the bark, flower, fruit, stem or branch.
In still another embodiment, the base used may be such as aqueous cream base (containing emulsifying ointment BP 1993, preservative and water) or gel base (containing propylene glycol, carbopol 934 and mondethanol amine).
In yet another embodiment, the preservatives used may be such as Methyl paraben, Propyl paraben, p-Chlorocresol.
In still another embodiment, the humectants used may be as Glycerine.
In an embodiment, the extract of Tagetes erecia is a water extract.
In still another embodiment, the extract of Moringa oleifera is a leaf extract.
In yet another embodiment, the extract of Ocimum sanctum is a steam distilled oil extract.
In another embodiment, humectant is glycerine and present in the range of 0.5 to 3 wt. %,
In an embodiment, the anti-inflammatory drugs are selected from Beta methasone valerate present in the range of 0.03 to 0.09 wt. %, Clobetasone propionate present in the range of 0.03 to 0.08 wt. %, Salicylic acid present in the range of 1 to 3 wt. % and Sandal wood oil in the range of 0.3 to 0.8 wt. %.
In yet another embodiment, Gum olibanum resinoid hexane extract ranges between 3 to 6wt. %.
In still another embodiment, the Gum olibanum organic extract is a Gum olibanum methanolic extract and ranges between 3 to 6 wt. %.
In another embodiment, the gel is a base containing propylene glycol, carbopol 934 and monoethanalamine.
In an embodiment, the base is an aqueous cream containing emulsifying ointment BP1993.
In another embodiment, the skin disorders are selected from the group consisting of Eczema and corns.
In still another embodiment, the formulation is used as anti-inflammatory agent and wound healing agent.
In another embodiment, the formulation is in the form of an emulsion of cream for application to the skin.
The invention also provides a method for the treatment of Eczema comprising the steps of application of the herbal formulation, to a subject in need thereof at least two times a day for a period of 90-120 days.
In an embodiment, the herbal formulation of the invention is applied at least two times a day for a period of 60-90 days for the treatment of Corn.
In yet another embodiment, the herbal formulation of the invention is applied at least two times a day for a period of at least two days for alleviating muscular pains.
As a result of intensive study conducted by the inventors with the aim of achieving aforementioned objectives, new processes for the preparation of cream formulations for topical use were developed employing herbal drugs which are from natural origin, incorporating them into cream bases along with synthetic materials which are known to possess water retaining properties.
Accordingly, the present investigation deals with cream and gel based topical formulations. Each formulation has been described in detail giving the formula of the ingredients along with method of preparation.
The first step in the preparation of these formulations involves a process for making the plant material suitable for incorporating into cream/gel bases. The specified portion of the plant is collected and dried under shade at room temperature in an enclosed room for 72 hrs or more until the material gets dried. A specified amount of material is then extracted with solvents like n-hexane, chloroform, ethanol, methanol and water, in cold condition. The choice of the solvent depends upon the type of material expected at the end of extraction process. Extraction process was carried out in a closed container immersing specified amount of the plant material in respective solvents for 72 hrs. At the end of this stage, solvent is decanted and filtered if necessary to make it free from the plant debris. The solvent is then concentrated by evaporating under vacuum at room temperature. If the solvent used is water, then concentrated solution is freeze dried to obtain the final product in, powder form. If the solvent used is a non-polar solvent then final product would be an oily and viscous substance with specific physico-chemical properties. This final product is made into a formulation intended for topical use by using it as an ingredient for making creams and gels. Suitable preservatives like methyl paraben, propyl paraben and p-chlorocresol have been used. Humectants such as propylene glycol and glycerol have been used in appropriate quantities.
Note:
The following are to be noted while making these formulations.
1. All the ingredients are expressed in % w/w basis.
2. Emulsifying ointment used in these formulations is prepared as per the procedure given in the official compendium (British Pharmacopoeia, 1993).
3. Carbopol 934 is a trade name given by the manufacturer. The generic name is Carbomer 934. It is a high molecular weight polymer of acrylic acid cross-linked with allyl ethers of sucrose. Carbomer 934, previously dried in vacuum at 80xc2x0 for 1 hour, contains not less than 56.0 percent and not more than 68.0 percent of carboxylic acid (xe2x80x94COOH) groups. The viscosity of neutralized 0.5 percent aqueous dispersion of Carbomer 934 is between 30,500 and 39,400 centipoise. Reference: United States Pharmacopeia/The National Formulary, USP 23/NF 18, 1995, United States Pharmacopeial Convention, Inc. 12601, Twinbrook, Parkway, Rockville, Md. 20852. Page 2226.